drugset / Trial / NCT00485134
Shigella Flexneri 2a Invaplex 50 Vaccine Dose Finding and Assessment of Protection
Phase 1/2
Completed
113 enrolled
U.S. Army Medical Research and Development Command
U.S. Army Office of the Surgeon General · collab
RandomizedParallel-groupDouble-blindPrevention
Summary
The purpose of this study is to select a safe and immunogenic dose of Invaplex 50 intranasal vaccine, and to assess protection of Invaplex 50 intranasal vaccine against diarrhea, dysentery, and fever following challenge with the Shigella flexneri 2a 2457T strain.
Timeline
- Start
- 2007-05
- Primary completion
- 2009-07
- Completion
- 2010-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Invaplex 50 | Vaccine | 240 ug | Intranasal |
| Subject | Invaplex 50 | Vaccine | 480 ug | Intranasal |
| Subject | Invaplex 50 | Vaccine | 690 ug | Intranasal |